Breast prostheses are usually made of a synthetic silicone resin that cures to a gelatinous state, and the outer surface of the prosthesis is shaped so as to simulate the shape of a woman's natural breast. As disclosed in U.S. Pat. No. 5,035,758 to Degler, a distinction is made between film-free breast prostheses and prostheses encapsulated or sheathed in film. Film-free breast prostheses have the disadvantage that silicone oil often seeps from the prosthesis. In order to overcome this disadvantage, breast prostheses have been encapsulated in thermoplastic films such as polyurethane films. In general, such breast prostheses are produced by placing the uncrosslinked silicone resin composition together with the crosslinking agent and a catalyst between two flat films that form an envelope for the prosthesis. The films are welded together along this edge except for a small filling opening. The films are then fixed at the edge of a cavity in the area of the welded edge in a die that corresponds to the shape of the breast. Silicone resin composition is added until the films are pressed against the walls of the die cavity, the film edges are then welded together in the area of the filling opening, and the silicone resin composition is cured to form a gelatinous mass. Breast prostheses of this type are described, for example, in U.S. Pat. No. 5,035,758 to Degler.
However, while known film encapsulated breast prostheses simulate the shape of the breast, they do not adequately simulate the natural shape, color and hardness of the areola and nipple regions of a human breast. The present invention provides an improved encapsulated gel breast prosthesis having a nipple and areola which simulates the natural nipple and areola in shape, color and hardness and provides a process for producing a breast prosthesis having such characteristics so as to provide a prosthesis which closely simulates a woman's natural breast.